Monday, 13 February 2017

The Specials Market in primary care was just over £80.5 million for the 12 month
period Oct 15 - Sep 16. Although the market
continues to decline year-on-year, it is now stabilising following a period of
readjustment in the wake of the Specials Tariff in November 2011. During this time the mean cost per item has
reduced from £180 per item before the tariff in Nov 2011, to an average £116
for the same 12 month period to Sep 2016.

Whilst this represents value for money to the NHS, at
the same time the high standards of quality involved in Specials manufacture
have needed to be maintained. According
to the Association of Pharmaceutical Specials Manufacturers, APSM, members report
continued investment in infrastructure and quality processes to meet the
increasing regulatory demands required by the sector.

To reflect the increased complexity of
the market, last year
(2016), the Association of Pharmaceutical Specials Manufacturers, APSM, decided
to broaden its membership criteria to the wider supply chain, including
importers as well as virtual Specials manufacturing organisations who own the
rights to, and act as the first supplier of, a Specials medicine in the UK.

In the last 5 years
following the introduction of the Specials Tariff there has been significant developments
in regulatory framework and professional guidance around Specials and the role
of the APSM has changed to be one of influencing and responding to issues in
this changing market – always with the aim of maintaining a robust quality
framework and best practice across the entire supply chain, not just
manufacture.

Said APSM Chair, Sharon
Griffiths, ‘Our ultimate goal is to maintain a sustainable Specials sector that provides high
quality, safe medicines to patients – we’re looking forward to working with
more organisations who share this vision.’Specials Spend 2015-16

Tuesday, 6 September 2016

The Association of Pharmaceutical Specials Manufacturers,
APSM, has broadened its membership criteria to include importers as well as virtual
Specials manufacturing organisations who own the rights to, and act as the
first supplier of, a Specials medicine in the UK.

Originally founded to
represent the interests of holders of a Specials Manufacturing Licence, the
APSM has an important role liaising with the DH and key policy makers as well as inputting into decisions around new
legislation and Specials guidance.

The decision to broaden membership to the wider supply chain reflects
the changing shape of the Specials market, particularly over the last 5 years following
the introduction of the Specials Tariff alongside a developing regulatory
framework and professional guidance around Specials. Influencing and responding to issues in this
changing market has also become a more important role for the APSM.

APSM Chair, Sharon Griffiths, said, “The decisions and actions we take
now have implications for the entire supply chain and we need to give other
organisations who have an interest in this market an opportunity to contribute
to those decisions.”

Our ultimate goal is to maintain a sustainable Specials sector
that provides high quality, safe medicines to patients – we’re looking forward
to working with more organisations who share this vision.

Monday, 1 August 2016

The APSM has launched our new website which is the definitive source of information about Specials in the UK. In addition to updated content about the role of Specials in the patient journey, there is detailed information about the regulatory framework for prescribing Specials and up-to-date market stats about the cost of Specials in the UK.

Designed for anyone involved in prescribing or dispensing Specials, the website contains lots of useful tools to support clinical understanding and decisions around the use of unlicensed medicines. There are also links to useful resources such as professional guidance and the Drug Tariff.

Says the APSM, the website is designed to promote the important role of Specials Manufacturers in helping to meet this important area of patient clinical need with high quality advice and product information.

Tuesday, 8 December 2015

An article published today (8 December 2015) in the Daily Mail ‘High
Street Chemists who charge the NHS £300 for skin creams that should cost £12’, contains
a number of significant inaccuracies about the Specials market and APSM
activities.

Here follows
the APSM response to the facts presented within the article.

DAILY MAIL QUOTE: The
practice has been exposed by the BAD which says up to £400m a year of
taxpayers’ money is being wasted on paying too much for these treatments. Even 2% salicylic acid cream which can be
effective for these conditions costs the NHS £75m per year.

APSM
Response: Dermatology Specials are a
small proportion of Specials spend in primary care – approximately £1m per year.

The
total spend on Specials in England in 2014 was £89.5million in primary care. A very small percentage of this is for
dermatology specials through community pharmacy.

Only
a small number of Dermatology products are in the top 500 specials*. In
the last 3 months to September 2015, 1404 items were prescribed for
topical use (which would include dermatology products) at a cost of
£259,360. Over a year this is approximately £1m. (Just over 1% of all spend).

Of
the 3 products mentioned specifically, Coal Tar 5% was 220 prescriptions in last
3 months less than£200,000 per year (average cost £180 - £190). Coal Tar 10% ointment 100g was 23 in the last
3 months – less than £30,000 a year. 2% salicylic acid in aqueous cream
100gwas 63 prescriptions in 3 months - approximately £50,000 over a year.These figures are based on data for England. The estimated value for Dermatology Specials in the community including Scotland and Wales is £1.2m (an additional 20%).

*The
NHS BSA lists the top 500 most reimbursed specials (in Primary Care) by cost
(NIC) and number of items. This includes
items on the Drug Tariff as well as those not included in the Tariff and covers
approximately 80% of the total spend on Specials each year.

DAILY MAIL QUOTE: In Scotland they are still supplied by NHS
prices but in England the pricing is governed by market forces

APSM Response:
The Scottish Tariff covers a smaller number of products (50) and uses a
different mechanism for setting prices, although commercial and NHS prices are also
taken into account. Overall, the price
of the majority products on the Specials Tariff in Scotland is similar to the
England Tariff with some fluctuations (some are cheaper in England than
Scotland and visa versa).

Certain dermatology products may have
been negotiated separately and we cannot comment on the process used.

The
Specials Tariff is designed by the
Department of Health to provide sustainability of supply and
a mechanism to ensure that safe and effective specials are available to the NHS
via a resilient supply chain that provides a fair return, ensuring the long
term sustainability of the specials market.
The DH has a mechanism for deciding which products will go on Tariff and
it is regularly reviewed.

DAILY MAIL QUOTE: “The creams are made by 14
member companies”

APSM RESPONSE: Of our 13 members only a
minority produce any of these creams and in very small volumes. APSM members report that they produce a
relatively small number of specials for dermatology supply to community
pharmacy. If they are asked to produce
them they are generally bespoke ‘one off’ preparations, i.e. the ingredients
are sourced and they are manufactured, quality checked and sent out the same
day.

APSM
Response: The product
examples used are not simple, effective or high street products.

Coal Tar is a
particularly difficult product to manufacture.
Although it has been used for hundreds of years in skin preparations,
there are concerns about its toxicity and known carcinogenic properties both
for patients and those involved in manufacturer, so it can only be manufactured
under special conditions. Pharmaceutical
standard coal tar as an ingredient is now very difficult to source – due to
recent changes in safety and quality regulations there are now only a very
limited number of raw ingredient suppliers worldwide and the cost has become
prohibitive – in fact many licenced manufacturers have had to cease manufacture. For these reasons, it is rarely used in
manufacture for licenced pharmaceuticals or Specials.

In
March 2013,
the MHRA (Medicines and Health Regulatory Authority) issued a warning about the
use of Aqueous Cream, particularly
for children with eczema as it may be an irritant. This is thought to be because of the, sodium lauryl sulfate (SLS), contained in
emulsifying wax which is one of the ingredients of aqueous cream. The National Eczema Society and NICE advise
caution in its use.

DAILY
MAIL QUOTE: Private manufacturers have
come in as part of the drive to open up the NHS to market forces, but as a
result patients and taxpayers are being penalised.

APSM Response: Commercial manufacturers were set up in
response to MHRA increased controls on specials quality and patient safety
following the ‘peppermint water case’ in 2000, in which an infant died after an
incorrectly formulated pharmacy preparation. Specials are now rarely made up in a community
pharmacy. There are a small number of
hospital manufacturing units which also have MHRA licences, but the commercial
sector exists to meet the majority of demand.

DAILY MAIL QUOTE: “The
NHS is charged more than £300 a pot for products that could cost just £12

APSM Response: If an NHS
manufacturing unit charges £12 then this reflects the price they charge, not
necessarily the cost of the product – this would not be sustainable in a normal
commercial environment. The full costs
of manufacture may have been allocated elsewhere within the NHS budget
(staffing, capital investment, etc).
Also, for some medicines they may have been able to manufacture a batch
in advance or at a later date and can achieve cost efficiencies this way, i.e.
they are not always operating a same-day service.

In England
and Scotland a number of Hospital Pharmacy units are supplying Specials
alongside commercial manufacturers and together we are providing essential
services to patients. However, most
in-house hospital units are not geared up to large volume production across
such a wide range of possible products so could not meet the demand for
Specials – particularly in England. Therefore the majority of capacity and
volume in the market comes from the commercial pharmaceutical manufacturing
sector and so the cost structure of the market has to be based on a commercial
rather than NHS funded model.

The Price Difference reflects the
commercial model

The main
purpose of Specials manufacture is to patient safety and to meet patient
clinical need. Commercial manufacturers
are required (by the MHRA) to carry sufficient capacity to meet demands on a
daily basis
with more than 20,000 potential preparations on systems, it is not possible to
predict demand so most orders are manufactured same day. For the average manufacturer this can be 2-500
different orders per day. There are
inherent costs involved with maintaining a high level of production capacity to
fulfil orders, as well as express delivery costs. This same-day manufacture also includes a
very stringent quality process (to pharmaceutical standards) – see attached –
to ensure patient safety. The costs associated with this
intensity of commercial manufacture are reflected in the price.

DAILY
MAIL QUOTE: “We have tried to discuss it with the APSM but says it doesn’t have
to talk to us”.

APSM
RESPONSE: “We made a direct approach to
BAD over a year ago to introduce ourselves.
We attended a meeting, shared information and agreed to attend future
meetings of their Specials Working Group.”

DAILY MAIL QUOTE: “Because
of a commitment to open the NHS to market forces and competition, the
Government has now prevented NHS pharmacies that manufacture these creams for
hospital use from also offering them through community pharmacies”

APSM
RESPONSE: “Our understanding is that any hospital pharmacy with an MHRA
specials licence can – and do - supply to community pharmacy.”

Thursday, 5 November 2015

The APSM, Association of
Pharmaceutical Specials Manufacturers, is reminding pharmacists of the
importance of 24 hour turnaround for bespoke Specials prescriptions. All APSM members sign up to a commitment of
timely delivery to patients1 and for all members that now means next
day delivery as standard. Members report that between 95-99% of orders are
despatched the same day of receipt for delivery the following.

Said, APSM Chair Sharon
Griffith, “What may have started as an effort to offer competitive advantage –
we’re happy to say is now the norm amongst APSM members which is good news for
patients. Patients who are prescribed Specials often
have a specific and urgent clinical need - they should not have to wait for
this medicine just because it isn’t a licensed or off the shelf preparation.”

Although Specials
manufacturers are geared towards bespoke manufacture it can still present a challenge. With more than 20,000 potential preparations
on our systems – we can’t predict what’s coming or think ‘we’ll save it and
make a batch next week’. An order is
received, it is manufactured, goes through QA and is despatched all within 24
hours. For a typical Specials
manufacturer this can mean 500 different orders a day – and of course the
inherent costs associated with express delivery costs and maintaining a high
level of manufacturing capacity so that orders can always be fulfilled.

As ongoing medicine
supply shortages result in longer waits for prescriptions, APSM is reassuring pharmacists
that Specials manufacturers are continuing to meet patient need on a daily
basis – 365 days a year. Continuity of
supply is being maintained in spite of the fact that Specials are unusual and
account for less than 1% of all prescriptions annually.

Said, Sharon, “We are
committed to maintaining a sustainable manufacturing base for Specials in the
UK and in spite of increased commercial pressure our APSM members have
continued to invest in high quality infrastructure and processes. In the last 5 years our members have
collectively invested over £100m in
service improvements – which is more than the value of the Specials market.

1. Members will at all times act in the interests of customers and ultimately patients with respect to the timely preparation and supply of Special medicines. It is recognised that members frequently supply on an urgent basis and will protocols and standards to supply in accordance with such timelines.

Tuesday, 15 September 2015

David Clough, Sales & Marketing Director for Eaststone
Specials, has been appointed Vice Chair of the Association of Pharmaceutical
Specials Manufacturers, APSM.

David has been in the Specials sector for five years working
for commercial licensed manufacturers. Prior to that he was at Goldshield
Pharmaceuticals. He steps into the APSM
role during an important phase in the development of the Specials sector. Said David, “Since the introduction of the
Tariff, the Specials sector is enjoying a period of stability and we are able
to focus our attention on building a high-quality, sustainable sector that
fulfils a critical role in supplying much needed medicines. Our focus in on working with our stakeholders
to ensure better knowledge and greater collaboration in decisions affecting
Specials and ultimately patients.”

“We are also keen to engage with commercial, licensed
manufacturers of Specials who are not currently members.”

The Chair of the APSM is Sharon Griffiths, Managing Director
of the Specials Laboratory.

Wednesday, 8 July 2015

There are
positive signs that the balance between cost and quality is being restored in
the Specials market – certainly according to the latest annual Specials Survey,
conducted by the APSM.

For the first
time since the survey began in 2012, fewer pharmacists are referring to CCGs as
the first source of advice about dispensing Specials (34% compared with 52.5%
in 2013), turning instead to RPS Guidelines (47.5%) or the GP (47%). However, there
is still evidence of pressure to reduce Specials spend with almost two thirds
of pharmacists stating that they are monitoring spend on Specials, or that they
are being asked by their CCGs to reduce or monitor Specials dispensing.

The APSM Survey also
points to the fact that pharmacists have a good understanding of Specials (over
75 % feel they have enough information or experience compared with 57% in 2013)
and have a positive view of the role of Specials, with 80% agreeing that they
are essential to meet the special clinical needs of some patients.

There is also
encouraging evidence that the practice of splitting or crushing tablets –
perhaps as an option to reduce cost – is losing support. 41.5% are comfortable to dispense tablets
with instructions to split or crush, compared with 52.7% in 2013. This is echoed in a parallel GP survey, which
showed the number who were comfortable to prescribe a licensed medicine in this
way has decreased slightly from 64.2% in 2013 to 53.5% today – although many
would argue that is still too high for such a potentially risky practice which
effectively renders the drug unlicensed.

Although there
is still concern that Specials may sometimes be prescribed unnecessarily, this
is reducing –to 35% of pharmacists respondents strongly agreeing (compared with
54.6% in 2013). We can see this
reflected in the fact that 43% of respondents said that they had declined to
dispense a Special in the past on the grounds of necessity or cost. This is potentially a good sign that
pharmacists are following guidelines and if necessary questioning the need or
formulation with the GP first. We know from a parallel survey of GPs that they
are in general much less knowledgeable about Specials (54% feel they don’t have
enough knowledge or experience) and the mechanisms are in place between
dispenser and Specials manufacturer to avoid unnecessary prescribing.

However, there
are anecdotal reports about patients sometimes being refused a Special on the
grounds of cost rather than necessity.
This is a matter of concern and our GP research shows that GPs are
certainly less confident and comfortable about Specials than pharmacists. GPs are in the frontline and facing difficult
decisions about balancing cost and quality.

The APSM
research still reflects an undercurrent of concern about cost, but this is not
exclusive to Specials. Everyone is
trying to find efficiencies across the NHS and we are all mindful of this. APSM members are operating in an increasingly
competitive environment – the demands of the MHRA are greater than ever in
terms of quality and this doesn’t come without a cost. The APSM is committed to continuing to meet these
standards required of us. There are no
short cuts to quality.

These are good
signs that initiatives such as The Tariff, RPS Guidelines, improved information
systems and quality infrastructure have resonated with pharmacists. Our research continues to underline that the
Specials Tariff has restored confidence in the supply chain (67.5% agree). As an industry we need to continue to work
with community pharmacists to ensure that they are well supported and continue
to get value from the Specials supply chain.

Source.
A survey of 200 Community Pharmacists and 200 GPs. Conducted by Opinion Health. May 2015